FDA Issues Draft Guidance on NCE Exclusivity for Combination Products
The U.S. Food and Drug Administration (“FDA”) recently issued Draft Guidance to the Industry, titled “New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products,” that proposes a change in its longstanding policy concerning 5-year new chemical entity (“NCE”) exclusivity for fixed-combination drug products. For many years, FDA’s interpretation of the word “drug” in certain provisions…